A Study on the Changes of Glucose Metabolism and Exocrine Function in Patients With Chronic Pancreatitis

NCT07314489 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Changzheng Hospital

Phase

Phase EARLY_PHASE1

Started

2025-04-01

Last updated

2026-01-02

Condition(s) studied

Chronic Pancreatitis Pancreatic Exocrine Insufficiency Blood Glucose

Investigational drug(s) / intervention(s)

Creon（Pancreatin Enteric-coated Capsules）

Creon（Pancreatin Enteric-coated Capsules）: This product is a mixture of various enzymes extracted from pig pancreas, mainly including trypsin, pancreatic lipase and pancreatic amylase.Take 1 tablet (0.3g) during meals, 3 times a day.0.3 grams is equivalent to 20,000 European Pharmacopoeia units of pancreatic lipase, 16,000 European Pharmacopoeia units of pancreatic amylase, and 1,200 European Pharmacopoeia units of pancreatic protease.

Study summary

This study aims to investigate the impact of pancreatic exocrine insufficiency on the glucose profile and pancreatic and gastrointestinal endocrine hormones in patients with chronic pancreatitis through pancreatic enzyme intervention in a reverse manner.

The primary objective is to observe the changes in glucose profile following pancreatic enzyme intervention in patients with chronic pancreatitis complicated by exocrine insufficiency and normal glucose metabolism.

The secondary objective is to observe the changes in pancreatic endocrine and exocrine functions and gastrointestinal endocrine hormone levels following pancreatic enzyme intervention in patients with chronic pancreatitis complicated by exocrine insufficiency and normal glucose metabolism.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Accepted

Inclusion Criteria: * 1\. Male or female Chinese subjects aged 18 years or older; 2. Patients with a clear diagnosis of chronic pancreatitis; 3. Glycated hemoglobin (HbA1c) levels between 4% and 6%; 4. FE-1 \< 100 µg/g. Exclusion Criteria: * 1\. A history of diabetes or prediabetes, or preoperative glycated hemoglobin (HbA1c) ≥ 6.0% or fasting venous glucose ≥ 6.1 mmol/L; 2. Positive for islet-related antibodies; 3. Patients who are currently receiving or have previously received pancreatic enzyme replacement therapy (PERT); 4. Allergy to the components of PERT drugs; 5. Exocrine pancreatic insufficiency (EPI) caused by other reasons, such as post-gastrectomy or post-intestinal resection; 6. Undergoing pancreatic surgery other than endoscopic retrograde cholangiopancreatography (ERCP); 7. Renal disease of stage G3, G4, or G5; 8. Decompensated chronic liver disease; 9. Receiving glucocorticoid therapy; 10. Pregnant or breastfeeding women; 11. Patients with malignant tumors.

Primary outcome measure(s)

The changes in glucose profile before and after pancreatic enzyme intervention — From enrollment to 3 months after pancreatic enzyme intervention

Trial sites (2)

Facility	City	Region	Status
Shanghai Changzheng Hospital	Shanghai	Shanghai Municipality	Recruiting
Changzheng Hospital	Shanghai	China	Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07314489 on ClinicalTrials.gov ↗ ← All trials in China